Head of Regulatory Affairs and Quality - Medical Devices M/F

Assembler and distributor of infusion and enteral nutrition devices, IMM France (International Medical Mediation) is a leading French SME in its market located in Belfort (90).

For 30 years, IMM France has been working alongside healthcare professionals, offering them medical devices that meet the highest standards of requirement. Present in home care and hospital settings, we develop devices for home-based antibiotic therapy, hydration, or chemotherapy, thus allowing patients to maintain optimal quality of life.

To support our development, we are looking for our new Head of Regulatory Affairs and Quality M/F.

Under the responsibility of the Managing Director,

• You are responsible for the regulatory compliance of our medical devices with the requirements of MDR 2017/745, LEA, and transparency standards.

• You are responsible for compliance with standards, quality and safety requirements, as well as product performance.

• In liaison with the certification body, you will lead the achievement of ISO 13485 certification. You will establish regulatory watch to get our products certified in various European countries.

• You will supervise actions related to vigilance and health surveillance.

• You will participate in the management of clinical studies and lead training sessions and webinars for our clients.

• You will develop our CSR policy and manage two project managers.

You have a Master's degree (Bac+5) in regulatory affairs and/or quality, as well as at least 5 years of proven experience in a pharmaceutical laboratory or another medical device company. You are proficient in MDR and ISO 13485 standards.

You aspire to join a human-sized structure that can involve you in an ambitious development project. You are proactive and enjoy teamwork. Organized, rigorous, and methodical, you know how to operate in a demanding regulatory environment. You are available to participate in conferences or other events. Good command of English is essential.

Position based in Belfort (90).

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